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Analysis of the Korea Food and Drug Administration Adverse Drug Reaction Reports (식품의약품안전청 약물유해반응 보고자료 분석)

  • Rhew, Ki-Yon;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.2
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    • pp.138-144
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    • 2011
  • In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

Factors Affecting the Adverse Drug Reactions of Mycophenolate Mofetil (Mycophenolate Mofetil 부작용 발생에 미치는 요인 분석)

  • Kim, Keum-Hi;Lee, Ju-Yeun;Park, Kyung-Ho;Son, In-Ja;Lee, Hye-Suk
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.2
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    • pp.151-158
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    • 2010
  • Therapeutic drug monitoring of Mycophenolate mofetil(MMF) has been suggested in some clinical trials, but has not been widely adopted in Korea. The purpose of this study was to analyze the withdrawal rates of MMF and determine the characteristics of the patients who experienced adverse reactions with MMF therapy and to suggest the criteria for selecting patients who need monitoring of MMF levels. We retrospectively collected data of patients who started MMF between July 2007 and June 2008. A total of 154 adult patients were included in our study. Among them, ninety seven patients discontinued MMF with 59 cases being due to adverse drug reactions. Thirty one patients required dosage reduction of MMF with twenty three cases being due to adverse reactions. Twenty six patients continued the MMF without or with mild adverse reactions. Of the 82 adverse reaction cases, hematologic adverse reactions accounted for 38 cases (46%) and gastrointestinal (GI) adverse reactions accounted for 28 cases (34%). Older age and lower serum albumin levels were significantly different characteristics between the patients who withdraw MMF due to hematological adverse reactions and those who were able to continue therapy. The group who experienced GI adverse reactions had higher MMF dosages based on body weight and lower serum albumin levels. In conclusion, the factors affecting the adverse reactions of MMF were age, serum albumin level and higher dosage, therefore therapeutic drug monitoring of MMF should be considered in these patients.

A Review on Cases of Skin Adverse Reactions through the Search for Articles (논문 검색을 통한 피부 부작용 사례 고찰)

  • Cho, Hye-Sin;Song, Ah-Ryun;Seo, Hyung-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.31 no.3
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    • pp.50-59
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    • 2018
  • Objectives : The aim of this review is to investigate studies on skin adverse reactions and to demonstrate subjects related to the adverse effects in dermatology. Methods : Electric searches were performed with KISS(Korean studies Information Search System) and the key words were combination of 'skin' and 'adverse effect'. 87 literatures investigated in this review were issued from 1900 to 2016. Results : Among the 87 papers, dermatologic adverse reactions were reported in 83 papers in medicine, accounting for 95.4%. Of the adverse effects seen on the skin, 84 discoloration such as erythema, pigmentation and hemotelangiosis were the most common, accounting for 21%. Among the medical adverse reactions not seen on the skin, 21 infection were the most common, accounting for 25%. Among the subjective adverse reactions, of which 32 pruritus were the most common, accounting for 43%. Among the 87 papers, there were 3 cases with underlying diabetes and 3 cases with underlying hypertension, followed by 2 cases with chronic renal failure, HBV, atopic dermatitis and respectively 1 case with alcoholism, depression addiction, multiple myeloma, arthritis and psoriasis. The most frequent period until adverse reactions appeared was within 2 weeks, accounting for 13 papers. And 4 were the most frequent adverse reactions lasting less than 1 month, and 4 were more than 3 months and less than 6 months. There were 48 cases where adverse reactions were caused by nonmedical practioner's treatment. The adverse reactions by the pharmacist were the highest at 11 cases (23%). There were 17 cases of adverse reactions due to medical treatment, among which dermatologists and nondermatologists accounted for the majority of 5 cases, 29%. The most common cause of adverse reactions was the application of external medicine (41 cases), followed by 36 cases of foreign body implantation, eyebrow tattooing, ear piercing, etc. Conclusions : In this report, we demonstrated patterns of adverse reactions in the medical field of dermatology caused by non-medical personnel than medical personnel. We suggest that more effort should be followed by medical personnel to establish clear awareness of skin disease and by patients to be aware of the risks of the illegal medical treatment by non-medical personnel.

Analysis of Adverse Reactions to Computed Tomography Contrast Medium (컴퓨터 단층촬영에 사용되는 조영제의 부작용 발생에 대한 분석)

  • Kwon, Ki-Soo;Jeong, Jae-Sim
    • Journal of Korean Biological Nursing Science
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    • v.6 no.2
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    • pp.57-68
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    • 2004
  • The contrast medium is very commonly used in more than 90% of computed tomography(CT) scans. It is difficult to predict the occurrence of adverse reactions and the degree of adverse reactions are diverse from mild urticaria, itching, nausea, vomiting to even cardiopulmonary arrest. The purpose of this study was to evaluate the symptoms, occurrence rate and risk factors of the adverse reactions in patients after contrast injection during CT examinations. Two hundreds sixty-five patients showed symptoms of adverse reactions out of 71,117 adult patients who received intravenous contrast administration during CT scans from January 2003 to December 2003 at a general hospital. Data was collected by reviewing adverse reaction records and electronic medical record. The results of this study were as follows; 1. Adverse reactions occurred in 265 out of a total of 71,117 patients(0.37%). Clinical symptoms of adverse reactions were most commonly dermatologic problems such as urticaria(69.81%) and itching(63.02%), followed by dyspnea(14.34%), dizziness(11.70%), nausea(6.79%), and vomiting(7.17%). 2. Anaphylactoid reactions occurred in 47 out of a total of 265 patients, and their pattern of symptoms were most commonly related to cardiovascular system(90.91%), followed by respiratory system(82.22%), gastrointestinal system(51.72%), and dermatologic system(16.51%). Eleven patients were transferred to emergency room for further treatment and two patients needed cardiopulmonary resuscitation. 3. The adverse reactions were significantly more common in women than in men(0.46% vs.0.32%, p=.003) and in type D contrast medium than the others(p<.001). The occurrence rate of adverse reactions was not significantly different according to the age and infusion speed of the contrast medium.

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Social Relief Scheme for Serious Adverse Drug Reactions - Lessons from other countries for Korea (외국의 의약품 부작용 피해구제제도 현황과 국내 실시 방안)

  • Park, Sylvia;Chae, Su-Mi
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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    • pp.18-27
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    • 2008
  • This study investigated social relief schemes for serious adverse drug reactions in foreign countries and deduced lessons and implications for Korea to implement the scheme. A social relief scheme for serious adverse drug reactions provides reliefs for diseases and such health effects as disabilities or deaths that were caused by adverse reactions to pharmaceuticals prescribed at hospitals and clinics as well as those purchased at pharmacies notwithstanding their proper use. The US and the UK do not have specific relief schemes for adverse drug reactions but apply rules of strict liability or negligence. New Zealand and Nordic countries provide no-fault compensation schemes for health effects or injuries caused by medical treatments or medicinal products. Japan and Taiwan have operated the schemes since 1980 and 2000, respectively. In designing the scheme in Korea, we suggested that cases eligible for relief be confined to serious adverse reactions such as death or disability and then extended to diseases. It is desirable to encourage the reporting system of adverse drug reactions and quality use of medicines for the relief scheme to work efficiently.

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Clinical characteristics of adverse reaction to radiocontrast media in children - A single center experience (소아에서 방사선 조영제 유해반응의 임상적 특징)

  • Kim, Min Jung;Lee, Bo Ra;Choi, Young Hun;Kang, Dong Yoon;Kang, Hye-Ryun;Suh, Dong In
    • Allergy, Asthma & Respiratory Disease
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    • v.6 no.6
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    • pp.315-321
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    • 2018
  • Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their characteristics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of adverse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was $12.7{\pm}3.2$ years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media.

Promotion of Adverse Drug Reactions Report through Expansion of Drug Utilization Review (의약품 사용평가(DUR) 확대를 통한 의약품 부작용 보고 활성화 방안)

  • Jeong, Su-Cheol
    • The Journal of the Korea Contents Association
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    • v.19 no.1
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    • pp.234-241
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    • 2019
  • The side effects of using drugs can greatly threaten the health of the public. The reality is that there are very few reports of current side effects. This can be activated by linking adverse drug reactions reporting to the Drug Utilization Review (DUR) currently used by pharmacies. A study of the U.S. medication management system, where drug use assessment is activated, can find ways to activate adverse drug reactions reporting. In 'Pharm IT 3000', which is used as a medication management program in pharmacies, we examined how to enable reporting of adverse drug reactions. The literature study and research on actual program operation have found a convenient way to report side effects by linking the Pharm IT 3000 prescription preparation assessment to the item.

Fentanyl PCA Monotherapy and Fentanyl TTS Combination Therapy in Post-Operative Pain Management: Analyses of Spontaneous Adverse Drug Reaction Reports (자발적 약물 이상반응 보고 분석을 통한 수술 후 통증 조절에 사용된 Fentanyl의 약물사용적정성)

  • Park, Soo Jung;Jeong, Kyeong Hye;Kim, Eun Young
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.2
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    • pp.81-87
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    • 2018
  • Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

Acute Adverse Reactions to Gadolinium-based Intravenous Contrast Agents for MRI : Retrospective Analysis Using Computed Reporting System (자기공명영상검사용 가돌리늄 경정맥 조영제의 급성 부작용: 부작용 전산 체계를 이용한 후향적 분석)

  • Choi, Moon-Hyung;Choi, Joon-Il;Jung, Seung-Eun;Ahn, Kook-Jin;Lee, Hae-Giu
    • Investigative Magnetic Resonance Imaging
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    • v.15 no.2
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    • pp.139-145
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    • 2011
  • Purpose : To assess the frequency and severity of acute adverse reactions to intravenous administration of gadolinium-based contrast agents using computerized reporting system at a single large academic institution. Materials and Methods : We assessed data from electronic hospital information system from October 2008 to December 2010. Reactions were classified as mild, moderate, or severe. We compared the frequency of adverse reactions among three contrast agents (Gd-BT-DO3A, Gd-DTPA and Gd-EOB-DTPA). Results : The total number of administrated contrast agents was 33,600, and the number of administration of Gd-BT-DO3A, Gd-DTPA and Gd-EOB-DTPA were 20,824 (62%), 10,417 (31%) and 2,359 (7%), respectively. Total 39 adverse reactions were reported accounting for 0.1161% of all administrations. The incidences of adverse reactions were 0.1248% (26/39, 67%) for Gd-BT-DO3A, 0.0768% (8/39, 21%) for Gd-DTPA, and 0.2120% (5/39, 13%) for Gd-EOB-DTPA. The difference of frequencies of adverse reaction among three contrast agents was not significant. Most cases of the adverse effect were mild (35/39, 89.7%). Moderate and severe adverse reactions were encountered in two patients, respectively. Conclusion : Among Koreans, adverse effects were rare, and especially, moderate to severe adverse reactions were much rarer. There was no difference among the frequencies of adverse reactions caused by three different contrast agents.